Efficacy of Music Therapy Protocols for Burn Debridement - Full Text View

Sponsors and Collaborators:	MetroHealth Medical Center The Cleveland Music School Settlement Kulas Foundation
Information provided by:	MetroHealth Medical Center
ClinicalTrials.gov Identifier:	NCT00822497

Purpose

The purpose of this prospective, crossover randomized study is to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels throughout the debridement process in individuals hospitalized with moderate to severe burns.

Condition	Intervention	Phase
Pain Management	Behavioral: Music-Based Imagery (MBI) Behavioral: Music Alternate Engagement (MAE)	Phase I

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	The Efficacy of Music Therapy Protocols for Decreasing Pain, Anxiety, and Muscle Tension Levels During Burn Debridement: A Prospective Randomized Crossover Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Burns

U.S. FDA Resources

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:

Pain, Anxiety, Muscle Tension levels [ Time Frame: 7 data points before, during, after debridement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Narcotics & Anxiolytics (dosage) [ Time Frame: Throughout debridement process ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2004
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Music-Based Imagery	Behavioral: Music-Based Imagery (MBI) MBI is form of music-assisted relaxation with imagery. This protocol is used at the patients' bedside before and after the debridement process.
2: Experimental Music Alternate Engagement	Behavioral: Music Alternate Engagement (MAE) MAE consisted of a menu of music therapy interventions aimed at engaging the patients in music and diverting them away from the debridement process.
Control: No Intervention Debridement under standard care with no music therapy interventions

Detailed Description:

The study is a prospective, randomized crossover clinical trial conducted on a 14-bed inpatient comprehensive burn care center. The purpose of this study is to investigate the efficacy of Music-Based Imagery (MBI) and Music Alternate Engagement (MAE) for pain and anxiety management for burn patients throughout the debridement process.

Eligibility

Ages Eligible for Study:	7 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is admitted for at least three days (excluding day of admission)
Patient is at least seven years old
Patient is able to communicate, i.e. awake and alert
Patient is oriented

Exclusion Criteria:

Patient admitted for/less than three days
Patient under seven years of age
Patient not able to communicate, i.e. sedated and/or intubated
Patient is not oriented, i.e. active psychosis, hallucinations, delusions, late-stage Alzheimer's or dementia diagnoses

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822497

Locations

United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109

Sponsors and Collaborators

MetroHealth Medical Center

The Cleveland Music School Settlement

Kulas Foundation

Investigators

Study Chair:	Xueli Tan, MM, MT-BC	The Cleveland Music School Settlement
Principal Investigator:	Richard B. Fratianne, MD, FACS	MetroHealth Medical Center

More Information

Publications:

Prensner JD, Yowler CJ, Smith LF, Steele AL, Fratianne RB. Music therapy for assistance with pain and anxiety management in burn treatment. J Burn Care Rehabil. 2001 Jan-Feb;22(1):83-8; discussion 82-3.

Fratianne RB, Prensner JD, Huston MJ, Super DM, Yowler CJ, Standley JM. The effect of music-based imagery and musical alternate engagement on the burn debridement process. J Burn Care Rehabil. 2001 Jan-Feb;22(1):47-53.

Responsible Party:	The Cleveland Music School Settlement ( Xueli Tan, MM, MT-BC )
Study ID Numbers:	99-00147
Study First Received:	January 13, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00822497 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:

music therapy
pain
anxiety
muscle tension

Study placed in the following topic categories:

Burns
Pain

ClinicalTrials.gov processed this record on September 01, 2009